Kornimate/medical-research-clean huggingface dataset:
the effect of frailty on balance, activities of daily, and exercise capacity in copd

Conditions: COPD; Frailty

Summary: the investigators aim to demonstrate whether balance, cognition and activities of daily living have changed in copd patients with and without frailty.

copd is a common, preventable and treatable disease characterized by progressive respiratory symptoms and airflow limitation. frailty defines a clinical syndrome characterized by multiple system effects, leading to decreased functional reserve and increased sensitivity to dependence or mortality following minor stress events. inflammation, lack of physical activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the development of frailty in patients with copd. balance, cognition and activities of daily living are associated with copd. this study will evaluate the effect of frailty on balance, cognition and activities of daily living in patients with copd.

Eligibility criteria:
inclusion criteria: * copd patients who have been clinically stable for the last four weeks and who have not undergone drug change for the last four weeks * being 55 years of age or older * accepted to participate in the study (able and wililing to complete the informed consent process) * co-operate * patients with copd who are ambulant without support or an assistive device exclusion criteria: * neurological, cardiac or orthopedic diseases * other chronic diseases that may affect balance and walking

Keywords: copd frailty balance cognition activities of daily living
laparoscopic total fundoplication for duodenogastroesophageal reflux

Conditions: Duodenogastric Reflux

Summary: after laparoscopic total fundoplication (ltf) 12-15% of patients have persistent reflux symptoms and 20-25% develop gas-related symptoms. reflux symptoms, gas bloating and inability to belch occurring after surgery have been associated with mixed (acid and weakly acid) (mr) or weakly acidic reflux (war). to date, few studies have evaluated functional outcome after ltf in patients with mr or war, with the majority reporting only short-term results. it has been shown that delayed gastric emptying (dge) might also be an important factor for abdominal distension and adverse outcome after ltf.9,10 however, the correlation between poor long-term outcome after ltf and dge is controversial. in addition, the effect of dge in patients with mr or war is poorly investigated.

in the last years the study of gastro-oesophageal reflux has been revolutionized by the development of combined 24-h esophageal ph and multichannel intraluminal impedance (mii) monitoring. combined esophageal mii and ph-monitoring allow for the timed correlation of esophageal ph changes with reflux events and achieve high sensitivity for the detection of acid (ph \ 7) reflux episodes. use of this technology is bringing into focus the potential role of weakly acidic and weakly alkaline reflux in symptoms that persist despite acid suppressive therapy or anti-reflux surgery.

Eligibility criteria:
inclusion criteria: - the study population consisted of consecutive patients with weakly acidic gastroesophageal reflux (ger) confirmed by 24 hour ph and impedance monitoring and eligible for laparoscopic antireflux surgery (lars). exclusion criteria: - exclusion criteria were presence of severe gastric emptying, functional heartburn, giant hiatal hernia, underlying primary esophageal motility disorder, american association of anaesthetists (asa) score iv, previous upper abdominal surgery, and contraindications to pneumoperitoneum.

Keywords: duodenogastroesophageal reflux weakly acidic reflux gastric emptying laparoscopic fundoplication
the pilot study of the efficacy of polymyxin-b hemoperfusion in critically ill patients with severe sepsis

Conditions: Severe Sepsis

Summary: this research project is a study to immunology changes in critically ill patients with severe sepsis by using endotoxin activity assay (eaa) combined with polymyxin-b hemoperfusion.


Eligibility criteria:
inclusion criteria: * sirs criteria \> or = 2 meets definition * source of infection \> or = 1 meet definition * evidence of organ dysfunction \> or = 1 meet definition exclusion criteria: * wbc \< 5,000 /ul * platelet \< 30,000 / ul * pregnancy woman * advance stage cancer patients (terminally ill) who is refuse to be resuscitated * received blood transfusion \> 5 units in 24 hrs * allergy to polymyxin-b * high risk and uncontrolled bleeding * organ transplant patients * on immunosuppressive agents within 2 weeks before study * hiv infection
efficacy and tolerance of cellularised lg002 versus uncellularised lg002 in the treatment of severe burns injuries

Conditions: Burns

Summary: after severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). this first covering is then replaced with thin skin meshed autograft. in this study, either the dermal substrates cellularised lg002 or uncellularised lg002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.

for lesions that cannot heal spontaneously, the wound is excised until fascia. four contiguous dermal substrates (uncellularised and cellularised) are randomly grafted on each symmetric area. a primary siliconized dressing will cover the wound. secondary dressing: dressing gauze impregnated with physiologic serum and/or sterile dried dressing gauze, the whole is maintained by a (slightly compressive) tubular or elastic bandage. thin skin meshed autograft will occur 14 to 21 days after dermal substrate cellularised lg002 or uncellularised lg002 grafting (time frame necessary for the site to vascularize). meshed autograft development must be identical in both symmetric areas, for one single patient.

Eligibility criteria:
inclusion criteria: * patients with severe burn injuries ≥ 40 % of tbsa (total body surface area) * thermal burn on symmetrical areas allowing grafting of 4 contiguous dermal substrates (cellularised lg002 or uncellularised lg002) on each area * the patient himself, or his legal representative, must give his informed consent in writing exclusion criteria: * anterior progressive serious illness (i.e severe hepatic insufficiency, immunodepression induced by corticotherapy or illness (aids)) * metabolic disease * systemic infection or local burn infection * known allergy to collagen, streptomycin, penicillin and/or bovine origine products
lactobacillus plantarum as therapy for nk-t cell deficiency

Conditions: Diabetes Mellitus

Summary: the etiology of immune-mediated diabetes mellitus (imd) remains unclear. however, previous studies indicate that autoimmunity may be a result of dysfunction of natural killer t cells (nk-t cells). newly diagnoses patients with imd have been shown in our laboratory to have significantly lower nk-t cells than normal controls. other studies have shown that oral administration of lactobacillus can boost nk-t cell activity in children with hiv without side effects. our objective is to evaluate the effect of lactobacillus administration on nk-t cell activity in patients with imd


Eligibility criteria:
recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes

Keywords: immune-mediated diabetes mellitus
ultrasound-guided peripheral vascular access in children

Conditions: Ultrasonography; Vascular Access Devices; Pediatrics

Summary: the purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by: 1. conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof. 2. ultrasound guided cannulation by means of dntp. the investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.


Eligibility criteria:
inclusion criteria: * requirement for anaesthesia before mri or operation. * routine need of peripheral intravenous cannulation. * age 0- 3 years at the date of mr scan exclusion criteria: * lack of consent * emergency patients needing immediate operation or scan.
a study to evaluate the safety/tolerability and pharmacokinetics of aliskiren in hypertensive pediatric and adolescent patients 6-17 years of age

Conditions: Hypertension

Summary: this first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.


Eligibility criteria:
inclusion criteria: * male or female, 6-17 years of age * documented history of hypertension as defined in national high blood pressure education program working group on high blood pressure in children and adolescents (2004) * must be ≥ 21.0 kg and ≤ 100.0 kg at randomization * able to safely wash out previous antihypertensive therapy for 1-2 weeks exclusion criteria: * body weight of \ 100 kg (220 lbs) * inability to discontinue prior antihypertensive medication as required during the washout period * any clinically significant abnormalities or clinically noteworthy abnormal laboratory values * renal artery stenosis * current diagnosis of heart failure (nyha class ii-iv) * mssbp ≥ 25% above the 95th percentile for age, gender, and height at visit 2 * second or third degree heart block with or without a pacemaker * atrial fibrillation or atrial flutter at visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to visit 1 * evidence of current symptomatic valvular disease other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: aliskiren pediatric hypertension pharmacokinetics (pk) pharmacodynamics (pd) plasma renin activity mini-tablet formulation
a tom training for people with multiple sclerosis: an efficacy study.

Conditions: Multiple Sclerosis

Summary: theory of mind (tom) is the ability to understand and attribute mental states to ourselves and others. people with multiple sclerosis (pwms) could present an impairment of this ability, with negative consequences on their social relationships and quality of life (qol). we aimed to design and implement a novel tom rehabilitation training, testing its efficacy on the promotion of emotional and mental states understanding, on qol and on the alexithymia traits.


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing-remitting (rr), secondary progressive (sp) and primary progressive (pp) ms; * age ≥ 18 and ≤ 75 years; * years of education ≥ 5; * no change of pharmacological treatment in the 6 months before the enrollment; * no clinical relapses or use of steroid treatment during 3 months before the enrollment; * provided informed consent for study participation. exclusion criteria: * history of nervous system disorders different from ms; * unstable psychiatric illness, such as psychosis or major depression; * severe disability with expanded disability status scale (edss) score \> 7.5; * severe cognitive impairment that would not enable pwms to answer to questionnaires correctly (i.e. dementia), according to the patient's medical records.

Keywords: theory of mind rehabilitation multiple sclerosis neurodegenerative disease
molecular biomarkers and adherent and invasive escherichia coli (aiec) detection study in crohn's disease patients

Conditions: Crohn's Disease

Summary: the study is a multicenter, international descriptive study with a bio-collection in 300 evaluable crohn's disease patients to be processed after usual biological tests via bioinformatics tools. at this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study.

350 crohn's disease patients will be included in the study, targeting 300 evaluable patients. an interim analysis will be performed after 50% of the evaluable patients are recruited. the primary objective is to evaluate the relation between non-invasive biomarkers (host immunological variables and metagenomic analysis in stools) and aiec detection in biopsies taken during an endoscopy, in order to develop a predictive algorithm of aiec carriage. the secondary objectives are: * validation of the aiec detection algorithm using qpcr technology. * assessment of the correlation between the presence of aiec and the endoscopic and clinical evaluations of the disease (cdeis, ses-cd, harvey-bradshaw index and crohn's disease activity index). * development and validation of a non-invasive qpcr based diagnostic of mucosal healing in cd patients. * collection of biological samples associated with all clinical and biological data from cd patients.

Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years of age, inclusive; * with a diagnosis of ileal or ileo-colonic crohn's disease for a minimum of 3 months prior to inclusion; * an ileocolonoscopy scheduled prior to study inclusion; * agreeing to participate and to sign an informed consent form; * able to perform stool collection, at home, according to protocol; * covered by health insurance system and/or in compliance with the recommendations of national law in force relating to biomedical research. exclusion criteria: * colonic crohn's disease of l2 phenotype based on montreal classification; * extensive small bowel resection (\> 100 cm) or short bowel syndrome * bowel strictures/stenosis contraindicating ilecolonoscopy; * currently with an ostomy or an ileoanal pouch; * currently receiving total parenteral nutrition; * bowel preparation received in the previous 3 months; * an increased risk of hemorrhage (patients with anticoagulant/antiplatelet therapy) * history of intestinal carcinoma and colorectal cancer; * history or presence of alcohol or substance abuse; * history of chronic uncontrolled disorders; * current participation in an investigational product trial; * less than 4 weeks since last participation in a clinical trial; * subject inapt or unwilling to participate to the study; * pregnant or breastfeeding mother; * patient under guardianship.

Keywords: aiec (adherent and invasive escherichia coli) mucosal healing non-invasive biomarkers
can tailored patient letters improve the quality of diabetic patient care?

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine if tailored letters sent to diabetic patients will improve care of diabetes.

diabetes care in the us is less than optimal. some authors have found that targeted patient letters are also an effective tool to improve outcomes when they are part of a comprehensive disease management plan. local patient satisfaction surveys had revealed that many patients had sub-optimal understanding of diabetes measures and of the importance of controlling these measures to reduce diabetic complications. we wondered if tailored patient letters and enclosed lab orders when due might increase patient awareness of diabetes measures and increase patient engagement.we hypothesized that the addition of targeted patient letters with enclosed lab orders to an ongoing performance improvement program would further improve diabetes care. we conducted a randomized controlled study of tailored patient letters and diabetes lab orders at our two resident-based clinics.

Eligibility criteria:
inclusion criteria: * all active patients age 18 to 75 years with a diagnosis of diabetes mellitus were eligible. * an active patient was defined as one having an icd-9 code on the active problem list identifying the patient as diabetic, and a progress note in the emr associated with an office visit within the prior 12 months. exclusion criteria: * none

Keywords: diabetes mellitus targeted mailing
arrhythmia restart prevention and rate stabilization in atrial fibrillation

Conditions: Sick Sinus Syndrome; Brady-Tachy Syndrome

Summary: the objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the selection 9000 and vitatron t70 dr pacemakers, dedicated to handle atrial fibrillation (af). two new algorithms (post-af response and ventricular rate stabilization \[vrs\]) will be assessed in a combined pathway, compared to a control group. the efficacy of the overall available therapies to prevent af and its symptoms will then be assessed also.

due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (af), interest towards preventive pacing treatments is increasing. the importance of this option in the panoply of the preventive tools is fully justified, only by considering the insufficiency, the complexity, or the poor reproducibility of the other non-pharmaceutical approaches. preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies, and more generally by stabilizing atrial tissue when potential triggers are appearing. on top of that, cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools, in terms of sensitivity, specificity and continuity in the monitoring. four preventive pacing therapies have already been evaluated, the objective of this study is to show the clinical benefit brought by the new features of the selection 9000 / vitatron t70 dr.

Eligibility criteria:
inclusion criteria: * patient with documented atrial fibrillation: at least one episode of paroxysmal af documented 6 months prior to inclusion, lasting more than one minute * patient with a brady-tachy syndrome or a sick sinus syndrome, with a permanent pacing indication * atrial lead with a tip-to-ring interval equal to or less than 12 mm * patient who agrees with and has signed the informed consent exclusion criteria: * permanent af * af related to a reversible cause * one electrical cardioversion 6 months prior to inclusion * unstable angina * myocardial infarction (mi) less than 3 months * planned cardiac surgery or performed in the last 3 months * congestive heart failure, new york heart association (nyha) class iv * life expectancy less than 18 months * patient participating in other studies * patient not able to follow the fu calendar * less than 18 years of age * pregnancy

Keywords: pacemaker atrial fibrillation prevention pacing algorithms sick sinus syndrome + atrial fibrillation
optical coherence tomography and nephropathy: the octane study

Conditions: Health; Hypertension; Chronic Kidney Disease

Summary: patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. part of this risk is due to changes in the structure and function of the blood vessels throughout the body. it is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. optical coherence tomography (oct) is a method of looking at the blood vessels at the back of the eye. it is a simple, quick and non-invasive test that you may have previously had during a visit to the optician. the purpose of the study is to ascertain whether oct is able to detect changes in the eye's blood vessels in patients with hypertension and chronic kidney disease compared to healthy individuals and also to see if any differences seen improve with treatment.

this project is an exploratory study, using enhanced depth imaging with the new spectralis oct, designed to examine choroidal and microvascular retinal structure in patients with hypertension, chronic kidney disease (ckd), and in age and sex matched healthy controls. the study is non-invasive and takes only a few seconds to acquire these complex images. the centre, where the images will be captured and where image analysis systems are located, is on the royal infirmary of edinburgh (rie) site close to the rie outpatient clinics, making recruitment easy.

Eligibility criteria:
inclusion criteria: * male or female * age 18-80 * body mass index ≤35 * for those with hypertension: bp ≥140/90 or on treatment for hypertension * for those with ckd: ckd as defined by the kidney diseases quality initiative guidelines exclusion criteria: * subject is below the age of legal consent, or is mentally or legally incapacitated * the subject has donated blood (450 ml) within the last 4 weeks * past or present drug or alcohol abuse including intravenous drug abuse at any time * participation in another clinical trial within 1 month * considered to be at high risk of hiv or hepatitis b * patients with known eye disease, or previous eye surgery, or refractive error greater than +/- 6 dioptres.

Keywords: oct; hypertension; ckd
gum health gel in post extraction sockets

Conditions: Impacted Third Molar Tooth

Summary: this research studies the effectiveness of the gum health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars

this research studies the effectiveness of the gum health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars which includes pain , swelling and trismus

Eligibility criteria:
inclusion criteria: horizontal and mesioangular impaction in healthy patients older than 18 years old - exclusion criteria:any medically compromised patient and the presence of any infection -
trans-cerebellar diameter and placental thickness in third trimesteric pregnant women for calculation of gestational age

Conditions: Gestational Age and Weight Conditions

Summary: pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.


Eligibility criteria:
inclusion criteria: * sure of dates * have dating ultrasound with crown rump length between (9 to 12 )weeks * no hormonal contraception 3 months before conception. * regular menstrual cycles. * medically free. * single pregnancy * gestational age 32-36 weeks exclusion criteria: * irregular menstrual cycles and not sure of dates * multiple pregnancy. * fetal anomalies. * placenta previa, placental anomalies and poor visualization of the placenta * fetal growth restriction * pregnant women with medical disorder e.g. diabetes mellitus, pre-eclampsia, systemic lupus erythromatosis, hypertension.
controller medications in the management of bronchial asthma

Conditions: Moderate to Severe Persistent Bronchial Asthma

Summary: the purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.


Eligibility criteria:
inclusion criteria: * aged between 15 to 65 years of either sex * had clinically diagnosed bronchial asthma * had poor asthma control defined by acq score (asthma control questionnaire) of 1.5 or greater * fev1 (forced expiratory volume at 1 second) value of 50% or more of predicted * improvement in fev1 was greater than 15% after bronchodilator inhalation exclusion criteria: * major illness of system other than respiratory major respiratory illness other than asthma taken long acting anti histaminic within a preceding week of enrollment smokers pregnant and lactating woman history of hypersensitivity to any of above drugs